Safety and Efficacy Study of ULTRASE® MT20 in Participants With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (PI)
|ClinicalTrials.gov Identifier: NCT00408317|
Recruitment Status : Completed
First Posted : December 6, 2006
Results First Posted : March 12, 2014
Last Update Posted : March 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis Exocrine Pancreatic Insufficiency||Drug: Ultrase® MT20 Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Multicenter, Randomized, Double-Blind, Crossover Study to Compare the Safety and Efficacy of Ultrase® MT20 to Placebo for the Correction of Steatorrhea in Patients With Cystic Fibrosis (CF)|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||April 2007|
U.S. FDA Resources
|Experimental: Ultrase® MT20||
Drug: Ultrase® MT20
Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in either first intervention period or second intervention period.
Other Name: Pancreatic enzyme product
|Placebo Comparator: Placebo||
Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in either first intervention period or second intervention period.
- Percent Coefficient of Fat Absorption (CFA) [ Time Frame: Day 3 to Day 7 in first intervention period and second intervention period ]Percent (%) CFA was calculated as ([fat intake - fat excretion]/fat intake)*100, determined by the stools collected during the 72-hour period which could extend to 96 hours during both intervention periods. Mean CFA percent was calculated for 72-hour/96-hour period during Day 3 to Day 7 in the first and second intervention periods.
- Percent Coefficient of Nitrogen Absorption (CNA) [ Time Frame: Day 3 to Day 7 in first intervention period and second intervention period ]Percent (%) CNA was calculated as [(nitrogen intake-nitrogen excretion)/nitrogen intake]*100, determined by the stools collected during the 72-hour period which could extend to 96 hours during both intervention periods. Nitrogen intake was calculated as protein intake/6.25. Mean percent CNA was calculated for 72-hour/96-hour period during Day 3 to Day 7 in the first and second intervention periods.
- Number of Bowel Movements [ Time Frame: Day 3 on first intervention period and second intervention period ]Number of bowel movements of each participant was calculated from frequency of stools by the participant per day. Mean daily number of bowel movements on Day 3 for the first treatment period and second treatment period was summarized.
- Percentage of Stool Categorized by Consistency [ Time Frame: Day 4 on first intervention period and second intervention period ]Stool consistency was categorized as hard, formed/normal, soft or watery stool. Percentage of stools of a specific consistency of each participant was calculated as the number of stools with a specific consistency relative to the total number of stools during the collection period. Mean percentage of stool with specific consistency on Day 4 for the first treatment period and second treatment period period for total participants was summarized.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00408317
|United States, Michigan|
|DeVos Children's Hospital|
|Grand Rapids, Michigan, United States, 49503|
|United States, Ohio|
|Rainbow Babies & Children's Hospital|
|Cleveland, Ohio, United States, 44106|
|United States, Pennsylvania|
|Pennsylvania State University, The Milton S. Hershey Medical Center|
|Hershey, Pennsylvania, United States, 17033|
|United States, Utah|
|University of Utah Health Sciences Center|
|Salt Lake City, Utah, United States, 84112|
|Study Director:||Aptalis Medical Information||Forest Laboratories|